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Targeted Irradiation as Bridging Therapy Prior to CAR-T Cell Therapy: A Pilot Study

A Pilot Study of Image-Guided, Three-Dimensional, Ultra-hypofractionated Radiotherapy as Bridging Therapy Prior to CAR-T Cell Therapy - SBRT as Bridging Therapy Prior to CAR-T Cell Therapy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032250263
Enrollment
10
Registered
2025-07-30
Start date
2025-07-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DLBCL or Multiple myeloma

Interventions

SBRT (30 Gy/3 fx)

Sponsors

Ito Kei
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis of either DLBCL or MM has been confirmed. 2. Lesion activity has been confirmed by FDG-PET/CT. 3. The patient is eligible for CAR-T therapy and has completed apheresis. 4. The lesion is not one for which dose coverage with ultra-hypofractionated radiotherapy would be significantly compromised. 5. The patient is 18 years of age or older. 6. The patient has an ECOG Performance Status (PS) of 0 to 2. 7. Written informed consent has been obtained from the patient after sufficient explanation and understanding of the study.

Exclusion criteria

Exclusion criteria: 1. Has serious comorbidities. 2. For patients with thoracic lesions as the target, clear evidence of interstitial lung disease is present on chest CT. 3. Women who are pregnant or may be pregnant. 4. Any other patients deemed unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of grade 3 or higher non-hematologic radiation-related toxicities within one year after enrollment.

Contacts

Public ContactKei Ito

Tokyo Metropolitan Komagome Hospital

keiito600601@gmail.com+81-3-3823-2101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026